NO20054711L - Methods and pharmaceutical compositions for the palpable uptake of acceptable serum testosterone levels - Google Patents

Methods and pharmaceutical compositions for the palpable uptake of acceptable serum testosterone levels

Info

Publication number
NO20054711L
NO20054711L NO20054711A NO20054711A NO20054711L NO 20054711 L NO20054711 L NO 20054711L NO 20054711 A NO20054711 A NO 20054711A NO 20054711 A NO20054711 A NO 20054711A NO 20054711 L NO20054711 L NO 20054711L
Authority
NO
Norway
Prior art keywords
serum testosterone
pharmaceutical compositions
palpable
uptake
methods
Prior art date
Application number
NO20054711A
Other languages
Norwegian (no)
Other versions
NO20054711D0 (en
NO335179B1 (en
Inventor
Jan-Peter Ingwersen
Doris Huebler
Sabine Fricke
Wilhelm Kuhnz
Original Assignee
Schering Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32748728&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO20054711(L) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Schering Ag filed Critical Schering Ag
Publication of NO20054711D0 publication Critical patent/NO20054711D0/en
Publication of NO20054711L publication Critical patent/NO20054711L/en
Publication of NO335179B1 publication Critical patent/NO335179B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/16—Masculine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Neurology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Dermatology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Abstract

Den foreliggende oppfinnelse vedrører farmasøytiske sammensetninger, formulert for injiserbar administrering, som omfatter en testosteronester, særlig testosteron-undecanoate, i en vehikkel som omfatter ricinusolje og et ko-solvent. Ved injeksjon av sammensetningene i henhold til et spesielt administrasjonsregime oppnås det pålitelige nivå av testosteron i serum i det normale fysiologiske området i lange tidsrom. Dette tillater anvendelse av sammensetningene i hormonerstatningsterapi og mannlig prevensjon uten samtidig overvåkning ved en lege av testosteronnivåene i serum.The present invention relates to pharmaceutical compositions formulated for injectable administration, which comprise a testosterone ester, in particular testosterone undecanoate, in a vehicle comprising castor oil and a co-solvent. By injecting the compositions according to a particular administration regimen, the reliable level of serum testosterone is achieved in the normal physiological range for long periods of time. This allows the use of the compositions in hormone replacement therapy and male contraception without concomitant monitoring by a physician of serum testosterone levels.

NO20054711A 2003-03-14 2005-10-13 Pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels, and use thereof NO335179B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200300399 2003-03-14
PCT/IB2004/000716 WO2004080383A2 (en) 2003-03-14 2004-03-15 Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels

Publications (3)

Publication Number Publication Date
NO20054711D0 NO20054711D0 (en) 2005-10-13
NO20054711L true NO20054711L (en) 2005-12-13
NO335179B1 NO335179B1 (en) 2014-10-13

Family

ID=32748728

Family Applications (1)

Application Number Title Priority Date Filing Date
NO20054711A NO335179B1 (en) 2003-03-14 2005-10-13 Pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels, and use thereof

Country Status (40)

Country Link
US (2) US7718640B2 (en)
EP (2) EP1743646A3 (en)
JP (1) JP4680891B2 (en)
KR (2) KR100882378B1 (en)
CN (2) CN1761469B (en)
AR (1) AR043603A1 (en)
AT (1) ATE336251T1 (en)
AU (1) AU2004218893B2 (en)
BR (2) BRPI0400214A8 (en)
CA (1) CA2518910C (en)
CL (1) CL2004000527A1 (en)
CO (1) CO5700724A2 (en)
CR (1) CR7999A (en)
CY (1) CY1105794T1 (en)
DE (1) DE602004001893T2 (en)
DK (1) DK1457208T3 (en)
EA (1) EA011568B1 (en)
EC (1) ECSP056095A (en)
ES (1) ES2271772T3 (en)
HK (1) HK1069325A1 (en)
HR (1) HRP20050781B1 (en)
IL (1) IL170473A (en)
IS (1) IS2565B (en)
JO (1) JO2505B1 (en)
ME (2) MEP14508A (en)
MX (1) MXPA04002395A (en)
NO (1) NO335179B1 (en)
NZ (1) NZ542321A (en)
PE (1) PE20041065A1 (en)
PL (1) PL1457208T3 (en)
PT (1) PT1457208E (en)
RS (1) RS51537B (en)
RU (2) RU2354381C2 (en)
SA (1) SA04250040B1 (en)
SI (1) SI1457208T1 (en)
TW (1) TWI345976B (en)
UA (1) UA82510C2 (en)
UY (1) UY28231A1 (en)
WO (1) WO2004080383A2 (en)
ZA (2) ZA200508313B (en)

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US20050152858A1 (en) * 2003-07-11 2005-07-14 Isp Investments Inc. Solubilizing agents for active or functional organic compounds
KR20080009201A (en) 2005-04-15 2008-01-25 클라루스 쎄러퓨틱스, 아이엔씨. Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
US8492369B2 (en) 2010-04-12 2013-07-23 Clarus Therapeutics Inc Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
AU2014200332B2 (en) * 2008-04-28 2016-10-06 Diurnal Limited Lipid composition
GB0807605D0 (en) * 2008-04-28 2008-06-04 Diurnal Ltd Lipid composition
US20120064166A1 (en) 2009-02-18 2012-03-15 Bayer Pharma Aktienesellschaft Formulation comprising drospirenone for subcutaneous or intramuscular administration
US9358241B2 (en) 2010-11-30 2016-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US20180153904A1 (en) 2010-11-30 2018-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US20120148675A1 (en) 2010-12-10 2012-06-14 Basawaraj Chickmath Testosterone undecanoate compositions
US20130178454A1 (en) * 2011-11-17 2013-07-11 Shalender Bhasin Combination of testosterone and ornithine decarboxylase (odc) inhibitors
US9950125B2 (en) * 2012-04-06 2018-04-24 Antares Pharma, Inc. Needle assisted jet injection administration of testosterone compositions
MX367123B (en) * 2012-05-09 2019-08-06 Univ Western Health Sciences Proliposomal testosterone formulations.
WO2014093818A2 (en) * 2012-12-14 2014-06-19 Bioject, Inc. Use of a novel subcutaneous needle-free technique to deliver testosterone in hypogonadal men
PT2953667T (en) 2013-02-11 2020-01-28 Antares Pharma Inc Needle assisted jet injection device having reduced trigger force
TW201521731A (en) * 2013-03-15 2015-06-16 利波辛股份有限公司 Lipobalanced long chain testosterone esters for oral delivery
WO2015023557A1 (en) * 2013-08-12 2015-02-19 Nanomedical Systems, Inc. Device and method for sustained release of low water solubility therapeutic agent in solubilizer
WO2015158823A1 (en) 2014-04-16 2015-10-22 Veyx-Pharma Gmbh Veterinary pharmaceutical composition and use thereof
WO2016033549A2 (en) 2014-08-28 2016-03-03 Lipocine Inc. (17-ß)-3-OXOANDROST-4-EN-17-YL TRIDECANOATE COMPOSITIONS AND METHODS OF THEIR PREPARATION AND USE
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CN105056115A (en) * 2015-08-05 2015-11-18 成都市飞龙水处理技术研究所 Oral medicine for treating purulent orchitis and preparation method thereof
US20180147215A1 (en) 2016-11-28 2018-05-31 Lipocine Inc. Oral testosterone undecanoate therapy
US11311554B2 (en) 2018-04-04 2022-04-26 Slayback Pharma Llc Pharmaceutical compositions of testosterone
CA3107214A1 (en) * 2018-07-20 2020-01-23 Lipocine Inc. Liver disease
KR102051808B1 (en) * 2018-07-23 2019-12-04 주식회사 종근당 Stable pharmaceutical composition comprising testosterone undecanoate
EA202191378A1 (en) * 2018-12-14 2021-10-04 Ацерус Биофарма Инк. ACTIVE ESTER DERIVATIVES OF TESTOSTERONE, THEIR COMPOSITIONS AND APPLICATIONS
WO2021067600A1 (en) * 2019-10-03 2021-04-08 Caren Pharmaceuticals, Inc. Combination hormone formulations and therapies
US20230227492A1 (en) * 2020-06-11 2023-07-20 The Usa As Represented By The Secretary, Department Of Health And Human Services Monomeric and oligomeric compound embodiments as contraceptives and therapies and methods of making and using the same

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Also Published As

Publication number Publication date
HRP20050781A2 (en) 2005-10-31
HRP20050781B1 (en) 2015-04-10
CA2518910C (en) 2009-09-08
ES2271772T3 (en) 2007-04-16
SI1457208T1 (en) 2007-02-28
HK1069325A1 (en) 2005-05-20
BRPI0400214A (en) 2005-02-09
CA2518910A1 (en) 2004-09-23
JP2006520377A (en) 2006-09-07
KR20080096717A (en) 2008-10-31
EP1457208B1 (en) 2006-08-16
EP1743646A3 (en) 2007-03-28
CL2004000527A1 (en) 2005-02-18
WO2004080383B1 (en) 2005-05-06
RS20050702A (en) 2007-06-04
US7718640B2 (en) 2010-05-18
ME00149B (en) 2010-06-10
EA200501819A1 (en) 2006-06-30
DE602004001893D1 (en) 2006-09-28
CR7999A (en) 2006-05-29
NZ542321A (en) 2008-05-30
IS2565B (en) 2009-12-15
US20090156564A1 (en) 2009-06-18
AR043603A1 (en) 2005-08-03
RU2005131724A (en) 2006-05-10
EP1457208A1 (en) 2004-09-15
AU2004218893B2 (en) 2008-10-09
IS8069A (en) 2005-10-12
TWI345976B (en) 2011-08-01
DK1457208T3 (en) 2006-12-11
RU2007118196A (en) 2008-11-27
UA82510C2 (en) 2008-04-25
RU2354381C2 (en) 2009-05-10
EA011568B1 (en) 2009-04-28
BRPI0400214A8 (en) 2023-05-09
WO2004080383A2 (en) 2004-09-23
RS51537B (en) 2011-06-30
NO20054711D0 (en) 2005-10-13
ECSP056095A (en) 2006-03-01
WO2004080383A3 (en) 2005-03-31
BR122017008910A8 (en) 2023-05-09
CN101884639A (en) 2010-11-17
ATE336251T1 (en) 2006-09-15
PT1457208E (en) 2007-01-31
PE20041065A1 (en) 2005-02-24
DE602004001893T2 (en) 2007-03-15
NO335179B1 (en) 2014-10-13
CN1761469A (en) 2006-04-19
SA04250040B1 (en) 2008-01-07
BR122017008910A2 (en) 2005-02-09
JO2505B1 (en) 2009-10-05
ZA200508313B (en) 2007-04-25
AU2004218893A1 (en) 2004-09-23
US8338395B2 (en) 2012-12-25
TW200511997A (en) 2005-04-01
MXPA04002395A (en) 2004-09-20
EP1743646A2 (en) 2007-01-17
JP4680891B2 (en) 2011-05-11
US20050032762A1 (en) 2005-02-10
UY28231A1 (en) 2004-11-08
MEP14508A (en) 2010-06-10
CY1105794T1 (en) 2011-02-02
IL170473A (en) 2010-05-31
KR20050109561A (en) 2005-11-21
PL1457208T3 (en) 2007-01-31
CN1761469B (en) 2019-05-17
KR100882378B1 (en) 2009-02-05
ZA200700046B (en) 2008-04-30
CO5700724A2 (en) 2006-11-30
EP1457208B9 (en) 2006-10-25

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